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DyspneaPhase 2tDCS-DYSP-REANCT03640455

Randomized Study Evaluating the Efficacy of Low Intensity Transcranial Electrical Stimulation (Tdcs) for the Relief of Dyspnea

A Phase 2 study testing Anodal and Cathodal in people with Dyspnea and Mechanical Ventilation Complication, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Nearly half (47%) of patients with mechanical ventilation in the intensive care unit report having dyspnea. This respiratory distress, with a feeling of "thirst for air", often reaches unbearable limits and is a major factor in the deterioration of the quality of life and the prognosis of patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dyspnea, Mechanical Ventilation Complication
What is being tested?
Anodal and Cathodal
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
63 participants
Where
1 siteFrance
Study dates
9 Nov 2018to 9 Jan 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patient, hospitalized in intensive care unit, presenting a sepsis, having required a mechanical ventilation since at least 24h.
  • Non-sedated or showing good wake up (Richmond Agitation-Sedation Scale score (RASS)> -3 at inclusion (Sessler et al., 2002)) within 48 hours after cessation of sedation
  • Patient able to answer by "yes" or "no" to simple questions
  • Showing significant dyspnea (level ≥ 4) on the A1 sub-scale of the Multidimensional Dyspnea Profile (MPD-A1 ≥ 4).
  • Signature of informed consent by the patient or his relative.

Who cannot join

  • Patient under guardianship,
  • Wake up delay, coma (GCS ≤ 8), or severe agitation.
  • chronic respiratory pathology
  • respiratory pathology, neuromuscular or neuro-sensory disability (auditory or visual).
  • Cranioplasty
  • Language barrier, refusal to participate in the study or to sign the informed consent,
  • Pregnant or nursing woman,
  • No affiliation to a social security scheme.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Raymond Poincaré

    Garches, 92380

Other trials in France

About this study

Official title: Etude Pilote Randomisee Versus Placebo Evaluant l'Efficacite de la Stimulation Electrique Transcranienne de Faible Intensite (Tdcs) Dans le Soulagement de la Dyspnee Chez Les Patients Sous Ventilation Mecanique en Reanimation

Nearly half (47%) of patients with mechanical ventilation in the intensive care unit report having dyspnea. This respiratory distress, with a feeling of "thirst for air", often reaches unbearable limits and is a major factor in the deterioration of the quality of life and the prognosis of patients. Physiopathological mechanisms of dyspnea are beginning better understood and have analogies with those of pain. Like pain, dyspnea often persists despite appropriate treatment of the cause, because of perceptual dysfunction related to changes in cortical excitability and neuronal plasticity and requires specific treatments. Studies have shown that Transcranial Stimulation by low Current (tDCS) was able to modulate the perception of acute pain induced and chronic pain. The tDCS modulates the functioning of a whole set of brain structures including the anterior cingulate gyrus, the prefrontal cortex, the thalamus and the brain stem, some of which have an established role in the central integration of pain and dyspnea. The investigators have recently demonstrated that the application of tDCS on the primary cortical motor area reduces the excitability of the central neurological pathways dedicated to the respiratory muscles in healthy subjects. The investigators therefore hypothesize that tDCS could relieve dyspnea in intensive care. In this research project, the investigators propose to evaluate the efficiency of tDCS on dyspnea in patients admitted to intensive care unit, having sepsis and mechanically ventilated.

Being tested
Placebo, Anodal, Cathodal
Medical subject headings
Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDevice

    A tDCS (Low Current Transcranial Stimulation) device with two electrodes: active and reference, will be used. The tDCS will be applied next to the cortical representation zone of the primary motor cortex and left pre-motor for 30 minutes; placebo (dummy stimulation), according to the patient's randomization arm.

  • AnodalDevice

    A tDCS (Low Current Transcranial Stimulation) device with two electrodes: active and reference, will be used. The tDCS will be applied next to the cortical representation zone of the primary motor cortex and left pre-motor for 30 minutes; intensity 2 mA, in anodal polarity, according to the patient's randomization arm.

  • CathodalDevice

    A tDCS (Low Current Transcranial Stimulation) device with two electrodes: active and reference, will be used. The tDCS will be applied next to the cortical representation zone of the primary motor cortex and left pre-motor for 30 minutes; intensity 2 mA, in cathodal polarity, according to the patient's randomization arm.

Study groups in NCT03640455
Study groupRoleWhat they receive
PlaceboPlacebo comparatorA tDCS (Low Current Transcranial Stimulation) device with two electrodes: active and reference, will be used. The tDCS will be applied next to the cortical representation zone of the primary motor cortex and left pre-motor for 30 minutes; dummy stimulation will be given.
Receives: Device: Placebo
Anodal tDCSExperimentalA tDCS (Low Current Transcranial Stimulation) device with two electrodes: active and reference, will be used. The tDCS will be applied next to the cortical representation zone of the primary motor cortex and left pre-motor for 30 minutes; Current Transcranial Stimulation (intensity 2 mA) will be given in anodal polarity.
Receives: Device: Anodal
Cathodal tDCSExperimentalA tDCS (Low Current Transcranial Stimulation) device with two electrodes: active and reference, will be used. The tDCS will be applied next to the cortical representation zone of the primary motor cortex and left pre-motor for 30 minutes; Current Transcranial Stimulation (intensity 2 mA) will be given in cathodal polarity.
Receives: Device: Cathodal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Differential of the Dyspnea

    Assessing differential of the Dyspnea Multidimensional Profile (MPD-A1) Scale A1 (from 0 to 10): between before (30 min before) and after (30 min after) the use of tDCS.

    The scale name is " Multidimensional dyspnea profile". The A1 dimension will be used and measures affective dimensions unpleasantness and overall breathing discomfort. The minimum score is 0 ( neutral) and the maximum score is 10 (unbearable discomfort).

    Measured: 30 min

Secondary outcomes (8)

  1. Differential of the QS

    Assessing differentials of the QS of the Multidimensional Dyspnea Profile measured between before and after the tDCS (MPD-QS scales) between before (30 min before) and after (30 min after) the use of tDCS.

    Measured: 30 min

  2. Differential of the A2 dimension

    Assessing differentials of the sale A2 of the Multidimensional Dyspnea Profile measured between before and after the tDCS (MPD-A2 scales) between before (30 min before) and after (30 min after) the use of tDCS.

    Measured: 30 min

  3. Differential of IC-RDOS

    Differential of Diagnostic Accuracy of Respiratory Distress Observation Scales (IC-RDOS scale) between before (30 min before) and after (30 min after) the use of tDCS.

    Persichini, R., Gay, F., Schmidt, M., Mayaux, J., Demoule, A., Morélot-Panzini, C., \& Similowski, T. (2015). Diagnostic accuracy of respiratory distress observation scales as surrogates of dyspnea self-report in intensive care unit patients. Anesthesiology: The Journal of the American Society of Anesthesiologists, 123(4), 830-837.

    Measured: 30 min

  4. Pre-inspiratory potentials (PIP)

    Presence of possible PIP on Electroencephalography (EEG)

    Measured: 1 day

  5. Death

    Measured: 28 days

  6. Delirium

    Cumulative incidence of delirium and its duration

    Measured: 28 days

  7. Mechanical ventilation

    Cumulative incidence of mechanical ventilation

    Measured: 28 days

  8. ICU length of stay

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2018
  2. Study start9 Nov 2018
  3. Primary completion9 May 2020
  4. Study completion9 Jan 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03640455
Sponsor's protocol ID
K160904
Acronym
tDCS-DYSP-REA
Status last verified
Nov 2021
First submitted
9 Jul 2018
Last updated
22 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Azabou E, Bao G, Heming N, Bounab R, Moine P, Chevallier S, Chevret S, Resche-Rigon M, Siami S, Sharshar T, Lofaso F, Annane D. Randomized Controlled Study Evaluating Efficiency of Low Intensity Transcranial Direct Current Stimulation (tDCS) for Dyspnea Relief in Mechanically Ventilated COVID-19 Patients in ICU: The tDCS-DYSP-COVID Protocol. Front Med (Lausanne). 2020 Jun 26;7:372. doi: 10.3389/fmed.2020.00372. eCollection 2020.

    PubMed 32671084

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anodal and Cathodal in people with Dyspnea and Mechanical Ventilation Complication, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differential of the Dyspnea (time frame: 30 min). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03640455, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.

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